Platform|API|Archive|Contact
Humanexa SignalsPharmaceutical Intelligence
Subscribe
Signals
Regulatory
  • FDA
  • EMA
  • MHRA
  • PMDA
  • Health Canada
Clinical
  • Phase I
  • Phase II
  • Phase III
  • Readouts
  • Enrollment Signals
Competitive
  • Pipeline Tracking
  • Company Moves
  • Asset Intelligence
  • Landscape Reports
Markets
  • Pricing
  • Access
  • Commercial
  • Launch Tracking
M&A Watch
  • Licensing
  • Acquisitions
  • Partnerships
  • Capital Raises
StrategyCatalystsPricing
Humanexa Signals

Data-driven pharmaceutical intelligence for biotech investors, pharma operators, consultants, and intelligence teams.

Powered by Humanexa

Categories

  • Regulatory
  • Clinical
  • Competitive
  • Markets
  • M&A Watch
  • Strategy
  • Catalyst Tracker

Company

  • Pricing
  • Partner with us
  • Subscribe
  • Contact
  • Privacy

Subscribe to Humanexa Signals

Weekly intelligence for pharma decision-makers.

No paywall. No spam. Unsubscribe anytime.

© 2026 Humanexa Signals. All rights reserved.

Intelligence powered by the Humanexa engine.

Company

Amgen

Pharmaceutical intelligence for Amgen with 22 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals
13
Catalysts
9
Assets
16

Recent signals(13)

RegulatoryJuly 31, 2026

Amgen's BLA761298 for PAVBLU Receives AP Status from FDA

The FDA has granted application BLA761298 for PAVBLU an Approval Pending (AP) status.

RegulatoryJuly 24, 2026

FDA Accepts Supplemental Application for NEUPOGEN by Amgen

The FDA has accepted a supplemental application for NEUPOGEN (filgrastim) from Amgen, indicating ongoing development.

ClinicalJuly 20, 2026

Amgen's MARITIME-2-EXTENSION Trial Evaluates Maridebart Cafraglutide for Obesity and Type 2 Diabetes

Amgen is conducting an extension trial to assess the long-term efficacy, safety, and tolerability of maridebart cafraglutide in patients with obesity and type 2 diabetes.

RegulatoryJuly 18, 2026

FDA Accepts Supplement for Repatha (Evolocumab) by Amgen

The FDA has accepted a supplemental application for Repatha (evolocumab) from Amgen.

RegulatoryJuly 15, 2026

FDA Accepts Supplement Application for WEZLANA (Ustekinumab-Auub) by Amgen

The FDA has accepted the supplemental application for WEZLANA, an IL-12/23 inhibitor.

ClinicalJuly 11, 2026

Interfant-21 Study on Blinatumomab for Infants with KMT2A-rearranged ALL

The Interfant-21 study evaluates blinatumomab in infants under 1 year with KMT2A-rearranged acute lymphoblastic leukemia.

RegulatoryJuly 8, 2026

FDA Accepts Supplement for BLA761333 by Amgen for Eculizumab-AEEB

The FDA has accepted the supplemental Biologics License Application (BLA) for BLA761333, which contains the active ingredient Eculizumab-AEEB.

RegulatoryJuly 8, 2026

FDA Accepts Application for PAVBLU (Aflibercept-AYYH) from Amgen

The FDA has accepted the application for PAVBLU, a biologic therapy containing Aflibercept-AYYH.

RegulatoryJune 27, 2026

FDA Submission Update for Prolia (Denosumab) by Amgen

Amgen has submitted a supplemental application for Prolia (denosumab) under BLA125320 with standard review priority.

ClinicalJune 21, 2026

Amgen's AMG 691 Phase 1 Study Targets Safety in Asthma Patients

Amgen is conducting Phase 1 study to evaluate the safety and tolerability of AMG 691 in healthy participants and those with mild-to-moderate asthma.

ClinicalJune 19, 2026

Amgen's Xaluritamig Plus Abiraterone Trial Targets Metastatic Prostate Cancer

Amgen is conducting a trial to compare overall survival in patients with metastatic castration-resistant prostate cancer receiving xaluritamig plus abiraterone versus standard treatments.

ClinicalJune 17, 2026

Gene Amplification Adjacent to F3 Linked to Poor Outcomes in Pancreatic Adenocarcinoma

Amplification of ARHGAP29 and SLC44A3 genes adjacent to F3 is associated with worse overall and disease-free survival in pancreatic adenocarcinoma.

RegulatoryJune 16, 2026

FDA Approves Bizengri for NRG1 Fusion-Positive Cholangiocarcinoma

The FDA has approved Bizengri (zenocutuzumab-zbco) for the treatment of NRG1 fusion-positive cholangiocarcinoma.

Upcoming catalysts(1)

Phase II Readout

Amgen — MariTide

Monthly dosing profile could differentiate Amgen in GLP-1/GIP competitive race.

June 25, 2026 · Phase II

Regulatory activity(8)

RegulatoryJuly 31, 2026

Amgen's BLA761298 for PAVBLU Receives AP Status from FDA

The FDA has granted application BLA761298 for PAVBLU an Approval Pending (AP) status.

RegulatoryJuly 24, 2026

FDA Accepts Supplemental Application for NEUPOGEN by Amgen

The FDA has accepted a supplemental application for NEUPOGEN (filgrastim) from Amgen, indicating ongoing development.

RegulatoryJuly 18, 2026

FDA Accepts Supplement for Repatha (Evolocumab) by Amgen

The FDA has accepted a supplemental application for Repatha (evolocumab) from Amgen.

RegulatoryJuly 15, 2026

FDA Accepts Supplement Application for WEZLANA (Ustekinumab-Auub) by Amgen

The FDA has accepted the supplemental application for WEZLANA, an IL-12/23 inhibitor.

RegulatoryJuly 8, 2026

FDA Accepts Supplement for BLA761333 by Amgen for Eculizumab-AEEB

The FDA has accepted the supplemental Biologics License Application (BLA) for BLA761333, which contains the active ingredient Eculizumab-AEEB.

RegulatoryJuly 8, 2026

FDA Accepts Application for PAVBLU (Aflibercept-AYYH) from Amgen

The FDA has accepted the application for PAVBLU, a biologic therapy containing Aflibercept-AYYH.

RegulatoryJune 27, 2026

FDA Submission Update for Prolia (Denosumab) by Amgen

Amgen has submitted a supplemental application for Prolia (denosumab) under BLA125320 with standard review priority.

RegulatoryJune 16, 2026

FDA Approves Bizengri for NRG1 Fusion-Positive Cholangiocarcinoma

The FDA has approved Bizengri (zenocutuzumab-zbco) for the treatment of NRG1 fusion-positive cholangiocarcinoma.

Clinical activity(5)

ClinicalJuly 20, 2026

Amgen's MARITIME-2-EXTENSION Trial Evaluates Maridebart Cafraglutide for Obesity and Type 2 Diabetes

Amgen is conducting an extension trial to assess the long-term efficacy, safety, and tolerability of maridebart cafraglutide in patients with obesity and type 2 diabetes.

ClinicalJuly 11, 2026

Interfant-21 Study on Blinatumomab for Infants with KMT2A-rearranged ALL

The Interfant-21 study evaluates blinatumomab in infants under 1 year with KMT2A-rearranged acute lymphoblastic leukemia.

ClinicalJune 21, 2026

Amgen's AMG 691 Phase 1 Study Targets Safety in Asthma Patients

Amgen is conducting Phase 1 study to evaluate the safety and tolerability of AMG 691 in healthy participants and those with mild-to-moderate asthma.

ClinicalJune 19, 2026

Amgen's Xaluritamig Plus Abiraterone Trial Targets Metastatic Prostate Cancer

Amgen is conducting a trial to compare overall survival in patients with metastatic castration-resistant prostate cancer receiving xaluritamig plus abiraterone versus standard treatments.

ClinicalJune 17, 2026

Gene Amplification Adjacent to F3 Linked to Poor Outcomes in Pancreatic Adenocarcinoma

Amplification of ARHGAP29 and SLC44A3 genes adjacent to F3 is associated with worse overall and disease-free survival in pancreatic adenocarcinoma.

Competitive activity

No signals indexed for this entity yet.

Assets

AMG 691 →
Bizengri →
BLA761298 →
Blinatumomab →
FDA →
Keytruda →
MariTide →
NEUPOGEN →
Obesity →
PAVBLU →
Prolia →
Repatha →
tarlatamab →
Trial Update →
WEZLANA →
Xaluritamig →

Therapeutic areas

23 →
Acute Lymphoblastic Leukemia →
Asthma →
Biologic Therapy →
Bone Health →
Bone Health · Osteoporosis →
Cardiovascular →
Cardiovascular · PCSK9 Inhibitor →
Complement Inhibition →
Endocrinology →
Endocrinology · Obesity and Type 2 Diabetes →
Hematology →
IL-12 →
Immunology →
Metabolic →
Neutropenia →
NRG1 Fusion-Positive Cholangiocarcinoma →
Obesity and Type 2 Diabetes →
Oncology →
Oncology · Acute Lymphoblastic Leukemia →
Oncology · Bispecific Antibodies →
Oncology · NRG1 Fusion-Positive Cholangiocarcinoma →
Oncology · Prostate Cancer →
Osteoporosis →
Pancreatic Adenocarcinoma →
PCSK9 Inhibitor →
Prostate Cancer →
Respiratory →
Respiratory · Asthma →
VEGF Inhibitor →

Indications

Acute Lymphoblastic Leukemia →
Asthma →
NRG1 Fusion-Positive Cholangiocarcinoma →
Obesity →
Obesity and Type 2 Diabetes →
Pancreatic Adenocarcinoma →
Prostate Cancer →

Newsletter

Get signals before the market moves

Concise strategic intelligence on regulatory, clinical, competitive, and market developments — free to subscribe.

No paywall. No spam. Unsubscribe anytime.